Last updated on December 2017

A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial


Brief description of study

A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial

Detailed Study Description

This study is a multi-center, randomized, double blind, placebo-controlled dose-response study designed to evaluate VF-001-DP as an adjunct to SC, versus Placebo and SC in the treatment of chronic VLUs. The SC therapy for VLUs is a moisture retentive ulcer dressing and multi-layer compression therapy. Mepitel® and Coban2® have been chosen to be used as SC in this study.

The study will have three (3) phases: Screening (2 weeks), Treatment Phase (13 weeks, with treatment up to 12 weeks) and Follow-Up (12 weeks).

Only patients whose study ulcer does not exhibit more than 30% change (increase or decrease) in ulcer size post-debridement between Screening Phase Visit (S1) and Treatment Phase Visit (T1) and who continue to meet eligibility criteria at T1 will be randomized to receive either the Active Treatment (VF001-DP low or high dose plus SC) or the Control Treatment (Placebo plus SC) in a ratio of 1:1:1.

Clinical Study Identifier: TX146476

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Maria Surprenant

Doctor Research Network
Miami, FL USA
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Irene Vayser

ILD Research Center
Carlsbad, CA USA
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Martin Lim

Alliance Research Centers
Laguna Hills, CA USA
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Onelia Fajardo-Garcia, MD

Miami Dade Medical Research Center (Dr Oliva)
Miami, FL USA
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Henrik Claeson

Advanced Foot and Ankle Center
Las Vegas, NV USA
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Joseph Cavorsi

Center for Advanced Wound Care PC
Wyomissing, PA USA
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Ozgu Tokgoz

Elemental Research Group
San Antonio, TX USA
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Maira Machado

Foot and Ankle Clinic
Miami, FL USA
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Maria Surprenant

Doctor Research Network (Dr Hanft)
Miami, FL USA
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Martha Daschbach

NorthBay Center for Wound Care
Vaccaville, CA USA
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Merlin Huici

Spotlight Research Center
Miami, FL USA
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Celso Figueroa

San Cristobal Hospital
Ponce, XX Puerto Rico
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Jailene Fraticelli

Mayaguez Hospital
Mayaguez, XX Puerto Rico
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Onelia Fajardo-Garcia, MD

Miami Dade Medical Research Center
Miami, FL USA
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Rozana Reyzelman

Bay Area Foot Care
San Francisco, CA USA
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Maira Machado

Foot & Ankle Clinic
Los Angeles, CA USA
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Krisztina Hanus

Foot & Ankle Clinic
Toledo, OH USA
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Alietta Espinosa

University of Miami Hospital
Miami, FL USA
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Zachary Gortler

University of North Carolina - Chapel Hill
Durham, NC USA
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Marcy Watchman

Southern Arizona Limb Salvage
Tucson, AZ USA
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Rozana Reyzelman

Sacramento Foot Ankle Cente
Sacramento, CA USA
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Angel Walker

Hyperbaric Medicin and Wound Care
Tacoma, WA USA
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Athens Sanchez

Barry University School of Podiatric Medicine
North Miami Beach, FL USA
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Maria Swartz

Barry University School of Podiatric Medicine
Miami, FL USA
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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